Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.
The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 6 Brazilian institutions. The study is already approved by a certified ethics committee. Funding is provided by a grant from São Paulo Research Foundation (FAPESP), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. A confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. All the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
440
Surgical access to the heart will be gained through a median sternotomy in all of the patients. In order to reduce the risk of bleeding and transfusions, an absorbable hemostat will be used in the sternal bone marrow. An automatic autotransfusion system will be used to recovery of red blood cells in all patients. Off-pump surgery will be performed with the use of heart stabilizers. Patients will be heparinized with 250 IU/kg intravenously to achieve activated clotting time \>200s. The proximal anastomosis will be performed according to our guidelines. The distal anastomosis will be constructed with the help of mechanical stabilizers and cardiac positioner. Intracoronary shunts will be used routinely.
Surgical access to the heart will be gained through a median sternotomy in all of the patients. On-pump surgery will be performed in normothermia, with the use of aortic cross-clamping and cold cardioplegic arrest. Patients will be heparinized with 500 IU/kg to achieve an activated clotting time \>480 s. Heparin will be neutralized with 1:1 protamine sulfate. The automatic autotransfusion system will be used just in massive blood loss to recovery the red blood cells. Surgical techniques will be performed according to our guidelines.
Emory University School of Medicine
Atlanta, Georgia, United States
Hospital de Messejana
Fortaleza, Ceará, Brazil
Hospital das Clínicas Samuel Libânio
Pouso Alegre, Minas Gerais, Brazil
Hospital Alberto Urquiza Wanderley
João Pessoa, Paraíba, Brazil
Instituto Nacional de Cardiologia de Laranjeiras
Rio de Janeiro, Rio de Janeiro, Brazil
Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, São Paulo, Brazil
Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
This composite outcome comprises: all cause death, acute myocardial infarction, stroke, renal failure, acute respiratory distress syndrome and bleeding reoperation
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Operative time
Operative time in minutes
Time frame: From the start of anesthesia induction to the end of the surgical procedure
Mechanical ventilation time
Mechanical ventilation time in hours
Time frame: From the initiation of mechanical ventilation in the operating room or ICU to the time of successful extubation
Hyperdynamic shock
A cluster of symptoms that signals the onset of septic shock, often including a shaking chill, rapid rise in temperature, flushing of the skin, galloping pulse, and alternating rise and fall of the blood pressure
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
New onset of atrial fibrillation
12-lead electrocardiography (ECG) to confirm the diagnosis of new onset atrial fibrillation.
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Need for pacing >24 hours
Patient who requires pacing \>24 hours
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Renal replacement therapy
Any type of renal replacement therapy in a patient who does not make continued use of this
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Pneumonia
Physician or advanced practitioner documents the diagnosis in the medical record based on laboratory findings (e.g. positive sputum culture results from transtracheal fluid and/or bronchial washings) and/or radiological evidence (e.g. chest radiograph diagnostic of pulmonary infiltrates)
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Length of stay in intensive care unit
Total time in hours in Intensive Care Unit
Time frame: From the date of surgery until ICU discharge, assessed up to 30 days
Length of stay in hospital
Total time in days in hospital
Time frame: From the date of surgery until hospital discharge, assessed up to 90 days
Transfusion requirement
Number of units of red blood cells transfused
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Recurrence of angina
To analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
Time frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Rate of complete revascularization
To evaluate and compare the rate of complete revascularization in each of the two strategies. Complete revascularization is defined as targeting arteries larger than 1.5 mm, with stenosis greater than 70%, and a good distal bed
Time frame: Assessed at the end of the surgical procedure, evaluated within the intraoperative period, with an estimated duration of up to 600 minutes
Evolution of frailty status
Frailty status will be assessed based on the Fried Frailty Criteria, which includes five components: unintentional weight loss, exhaustion, weakness (grip strength), slowness (gait speed), and low physical activity. Patients will be categorized as robust (0 criteria), pre-frail (1-2 criteria), or frail (3-5 criteria) at baseline and at follow-up. Changes in frailty status over time will be evaluated to determine progression, stability, or improvement
Time frame: From the date of hospital discharge until 6 months postoperatively and from the date of hospital discharge until 12 months postoperatively, assessed up to 1 year
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